L-TEK D.O.O.

FDA Device Registration & Listing · Sentjernej Ljubljana, SI · Registration 3015282442

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015282442
FEI Number
3015282442
Entity Name
L-TEK D.O.O.
City/State/Country
Sentjernej Ljubljana, SI
Establishment Address
Cesta Milosa Kovacicia, Sentjernej Ljubljana 8310, SI
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
L-Tek d.o.o. (Owner Number: 10059897)
Owner / Operator Contact Address
Cest Milosa Kovacicia, Sentjernej, SI-061 8310, SI
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Nushu Sleepiz

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ISD Exerciser, Measuring Physical Medicine Class 2 890.5360 2026-01-18
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2023-08-31
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2023-08-31

Official Correspondent

No official correspondent registered.

US Agent Details

Joseph Azary Business: Aztech Regulatory and Quality LLC Email: aztechregulatory@gmail.com Phone: (203) 2426670

Related Public Records

Same Entity

L-Tek d.o.o.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K913749 Edentec Corp. EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 1992-07-02
K771407 Research Development Corp. LUNG VOLUME & PRESSURE MONITOR 1977-08-04
K122223 Philips Medizin Systeme Boeblingen GmbH NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO 2013-04-12
K832250 Litton Medical Electronics SERVOMED BASIC BEDSIDE UNIT SMA 102- 1984-06-01
K801515 Abbott Medical Electronics Co. ABBY II PATIENT MONITOR OR VITAL SIGNS M 1980-07-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015282442. Last updated year: 2026. Please use registration number 3015282442 when referencing this establishment in official correspondence.
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